The influence of impaired salty taste thresholds and salt intake on annual decline of eGFR in patients with diabetes

Acronym

The impact of salty taste thresholds and salt intake on diabetic nephropathy

Scientific Title

The influence of impaired salty taste thresholds and salt intake on annual decline of eGFR in patients with diabetes

Scientific Title:Acronym

The impact of salty taste thresholds and salt intake on diabetic nephropathy

Region

Japan

Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Objectives

Narrative objectives1

The aim of this study is to evaluate the influence of estimated daily salt intake and salt taste thresholds on the decline of renal function in patients with diabetes. We also investigate the risk factors, such as diet, exercise and life style, which might influence on the decline of renal function.

Basic objectives2

Others

Basic objectives -Others

Research for the risk factors, which will cause renal dysfunction

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

To evaluate diet, exercise and life style, which might influence on the annual decline of renal function. We also evaluate clinical examinations below to find out the correlation between these variables and the decline of the renal function.
eGFR, urinary albumin/ creatinine ratio, urinary liver-type fatty acid-binding protein, urinary N-acetyl-beta-D-glucosaminidase, urinary beta2-Microgrobulin, urinary adiponectin

Key secondary outcomes

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients with type 1 and type 2 diabetes
2. Patients who signed the agreement with this study

Key exclusion criteria

1. Patients with remarkable dysgeusia
2. Gestational diabetes mellitus and specific types of diabetes due to other causes
3. Patients with kidney disease, which is not associated with diabetes
4. Patients who are considered inappropriate by the attendant physician

Target sample size

250

Research contact person

Name of lead principal investigator

1st name

Munehide

Middle name

Last name

Matuhisa

Organization

Tokushima University

Division name

Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences

Zip code

770-8503

Address

3-18-15, Kuramoto-cho, Tokushima

TEL

088-633-7587

Email

matuhisa@tokushima-u.ac.jp

Public contact

Name of contact person

1st name

Hiroyasu

Middle name

Last name

Mori

Organization

Tokushima University

Division name

Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences